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Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss

Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02105441
Acronym
CI and SSD
Enrollment
40
Registered
2014-04-07
Start date
2014-03-31
Completion date
2018-03-31
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Unilateral Sensorineural Hearing Loss

Keywords

cochlear implant

Brief summary

Do adults and children over 7 years of age with unilateral or assymetric hearing loss benefit from cochlear implantation on the worst hearing side.

Detailed description

Unilateral hearing loss is known to impair binaural hearing abilities. Specifically, localization, speech understanding in noise, and binaural squelch suffer due to lack of binaural timing and level cues. This study is designed to examine how binaural hearing is improved following cochlear implantation on the impaired side. The study endpoints are collected at 6 months and 12 months post activation of the implant. This is not a funded study. All costs are billed through insurance for reimbursement. There is an insurance approval process that we move through after a participant has been evaluated at the Mayo Clinic and found to be a candidate for cochlear implantation.

Interventions

DEVICECochlear implant

Implantable hearing device

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults * 18 years of age or older, * Hearing loss in the ear to be implanted must such that speech understanding is not possible with a well fitted hearing aid. Specifically, less than 40% monosyllabic word understanding when that ear is tested in the best-aided condition and the other ear is sufficiently occluded or masked. * Onset of hearing loss in the adult group must be post-lingual (after three years of age) Children * Children 7 years of age and older * Hearing loss in the ear to be implanted configured such that word understanding is less 40% in the best aided condition * Onset of hearing loss in the pediatric group must be post-lingual (after three years of age)

Design outcomes

Primary

MeasureTime frameDescription
Listening Effortone year post operative test timeA dual task performance paradigm will be used in which both the primary task and the secondary task will be performed simultaneously. The primary task will consist of speech recognition testing in varying levels of background noise and quiet, whereas the secondary task will consist of a motor reaction to a randomly presented light

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026